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ARTICLE IN BRIEF

Alzheimer disease investigators discuss the challenges of getting federal funding for new research.

Rochelle E. Tractenberg has two PhDs, 15 years of experience, a mentored “K” grant, and has co-authored more than 50 papers and book chapters. Specializing in biopsychology and statistics, Dr. Tractenberg has focused on Alzheimer disease (AD) research, looking at how changes in the brain affect behaviors. But now Dr. Tractenberg, assistant professor of neurology at Georgetown University, spends “90 percent of her waking hours applying for grants” and has shifted the focus of her research mostly to traumatic brain injury. She is applying to the National Science Foundation, the Veterans Administration, and the National Academy of Education, but not the National Institute of Aging (NIA), which funds 75 percent of AD research. “I'm not even applying to the NIA anymore,” she said. “It takes about four months to put together a grant together, and another six to get a response, and the chances of getting funded are so small.”

NIA Director Richard Hodes, MD, acknowledges the challenges. He said that about 8 percent of all grants are funded the first time investigators apply, but those who don't make the first approval round are allowed to reapply once, to basically revise their grants and reapply. It's unclear exactly what the final success rate is but it's “significantly higher,” he said, adding that the final FY2010 numbers are not yet available.

FUNDS ERODED BY INFLATION

According to the NIH Web site, the funding for AD has dropped from $643 million in 2006 to an estimated $269 million in 2010. That does not include $58 million in stimulus funds from the American Recovery and Reinvestment Act of 2009 (ARRA).

“Overall, our funding has been eroded by inflation — with an approximately 17 percent decrease in inflation-adjusted dollars since FY2003,” Dr. Hodes said. “The funds available in FY2011 are therefore limited. We will be making the decision in the next one to two months on how to use these funds to support applications, including consideration of differential funding criteria for more expensive versus less expensive applications. The question is what the agency can do to open the funding pipeline and mitigate long-term consequences.”

“We're very concerned that having a payline that is lower is going to have extremely negative consequences,” said Dr. Hodes. “The importance of aging research and the quality of application is high, and we're funding what we can right now. “The agency funds several of the largest AD projects, including $40 million of the $60 million, five-year Alzheimer's Disease Neuroimaging Initiative. The agency also saw an increase in R01 applications asking for more than $500,000 in funding, while R03 research, typically less than $50,000-$100,000, decreased.

So the NIA has put a moratorium on new genome-wide association studies, for example, research that might examine genetic variations associated with specific diseases. The agency is also considering having different requirements for less expensive research. Grant applications larger than $500,000 may have to receive special permission from program staff before submission to cut down on the size of the grants. It is a rule that has always been on the NIH books, but will be applied with greater stringency, said Dr. Hodes.

“It's a very strong priority to reach a payline that does not discourage people from the field, and that has to be addressed,” said Dr. Hodes.

THE EFFECT ON RECRUITMENT

Paul Aisen, MD, director of the Alzheimer's Disease Cooperative Study and professor of neurosciences at the University of California at San Diego, said that although he continues to have “substantial” funding through the NIA, it is difficult to recruit new investigators into a field because of the funding challenges.

“I know a lot of young investigators who are struggling — they've gotten a first grant but then that's it,” he said. “I've seen a lot of them leave, leave the AD field, leave the industry.”

Alzheimer advocates are asking Congress to fund an additional $2 billion for AD research, but officials said they're bracing for a cut, just in case.

“I think the general public attitude right now is that we need to reduce spending and I understand that, because we're greatly in debt and struggling to get out of the recession,” said Dr. Aisen. “But this is an area that's essential – the population that is growing dramatically at an age that's at huge risk for AD and the impact on health care costs and simply the suffering of families is enormous. It has to be addressed.”

Walter J. Koroshetz, MD, deputy director of the NINDS, said they fund about 13-14 percent of applications, with particular consideration for new investigators at about 20 percent.

The NINDS began to trim down some of its larger projects in 2004-2005, he said. “We started to sunset programs that had been going on for 10 years and some were running 30 to 40 years,” Dr. Koroshetz said.

WANING STIMULUS FUNDS

There is concern across both agencies that the stimulus funding handed out in the past two years, will come back to haunt researchers when they try to renew. But both Drs. Koroshetz and Hodes said there has not been a rush of new applications.

“We think the people who got the ARRA money might have already had NIH funded programs, so they used the stimulus money to try something new,” said Dr. Koroshetz. “So when they resubmitted their grants on the regular cycle, their research might have changed.”

Some of the stimulus money went to one-time programs, such as setting up disease registries to collect data or to pilot new research that might now be ready for a phase 3 clinical trial, he said.

WHAT DOES THE FUTURE HOLD?

Ronald C. Petersen, MD, PhD, director of the Mayo Alzheimer's Disease Research Center who serves on the National Advisory Council on Aging, said that although his research is funded out to 2014, the center is already thinking about how it might expand its focus on funding sources and consider studying additional conditions such as Parkinson disease (PD).

“We have this great group of 2,000 to 3,000 people between 70-89 years of age who are not suffering from dementia, who are normal, and our goal is to evaluate them for predictors of AD dementia,” Dr. Petersen said. “Can we detect biomarkers and clinical signals to predict who will get AD in the future so that when treatments become available, the earlier we intervene the better?”

“While that works for AD, we could ask the same questions of PD,” he said. And while Dr. Petersen races to get funding for his own center, he also worries about the future of AD research.

“We may miss a generation of new investigators so that 10-15 years down the road, there's going to be a real gap of young minds,” he said.

For Dr. Tractenberg, of Georgetown University, she's already moving on. “There are two problems with the zcurrent funding situation,” she said. “Earlier, when senior investigators were getting grants, they were able to make some of those funds available to junior investigators — maybe it was in pilot funds, or time in the lab. There was very much this trickle down effect from senior to junior investigators.”

“Additionally, the senior faculty did not have to spend 90 percent of their own waking hours applying for grants, so they were able to better mentor junior researchers. That's probably the most significant problem — the lack of mentorship. Everyone is completely focused on their lab; they can't sit down and spend time to read my application. Without targeted, constructive input, I cannot grow as a scientist.”

Dr. Hodes said he hears those concerns and shares those worries. “It's not a pleasant time,” he said. “In some way, we're fortunate that we have not seen a large increase in applications, because our ability is already strained. But we are committed to sustaining the payline and keeping investigators involved in aging research.”

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